Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000083291
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
4/02/2009
Date last updated
10/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Double-blind, Placebo-controlled Study of the Dosaging of AMPLIGEN 'Registered trade mark' (POLY I: POLY C12U), an Immunostimulant, in Conjunction With Influenza Vaccination
Scientific title
A Randomized, Double-blind, Placebo-controlled Study of the Dosaging of AMPLIGEN 'Registered trade mark' (POLY I: POLY C12U), an Immunostimulant, in Conjunction With Influenza Vaccination in active healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 4039 0
Condition category
Condition code
Infection 4242 4242 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Vaccination using AMPLIGEN 'Registered trade mark' to augment the response to influenza vaccination.
2. Three treatment groups (6 patients each) will recieve an intramuscular (IM) injection of the immune stimulant. One of these three groups will recieve the injection 2 hours before the vaccine, another group will recieve the injection of the immune stimulant immediately before the vaccine injection and the third and final group will recieve the injection of the immune stimulant immediately after the vaccine.
Dosing: Poly I:poly C12 U (Ampligen 'Registered trade mark') (200mg) and placebo will be supplied as solutions (80ml) ready for injection in identical 100 ml glass bottles. 1ml will be drawn up into a syringe and 2mg injected into the deltoid muscle of the subject's non dominant arm.
3. Patients will be dosed twice over a 6 week period.
Intervention code [1] 3759 0
Prevention
Comparator / control treatment
Placebo (Saline solution)
1. The study will utilize a placebo control consisting of 12 patients and that group will recieve a placebo injection in addition to the vaccine intramuscularly. In these subjects, four subjects will get their injections 2 hours before the vaccine, four subjects will get the IM injection immediately before the vaccine and the final four subjects will get their injection immediately after the vaccine. The placebo and the immune stimulant will be blinded to all parties in the study.
2. Poly I:poly C12 U (Ampligen 'Registered trade mark') (200mg) and placebo will be supplied as solutions (80ml) ready for injection in identical 100 ml glass bottles. 1ml will be drawn up into a syringe and 2mg injected into the deltoid muscle of the subject's non dominant arm.
Control group
Placebo

Outcomes
Primary outcome [1] 5128 0
1. To evaluate the impact of the time between dosaging of a two component vaccination system on the safety effect. Ampligen, an immunostimulant, will be evaluated in conjunction with influenza vaccination.
The first stage (Stage I) is a prospective study
2. Safety will be measured by the collection of adverse events and the review of laboratory parameters
3. The immunization effect will be measured by the Haemagglutinnation Inhibition Antibody assay and Seroconversion.
Timepoint [1] 5128 0
6 weeks
Secondary outcome [1] 8631 0
1. The second stage is to evaluate the safety response to the vaccine.
2. Safety assessment:
Vaccination site
- Induration greater than 50 mm present at 72 hours post vaccination
-Pain present at 72 hours
- Tenderness present at 72 hours
- Ecchymosis
Test agent site
- Induration greater than 50 mm present at 72 hours post vaccination
- Pain present at 72 hours
- Ecchymosis
Temperature higher than 38 degrees celcius for 24 hours
Malaise
Shivering/Rigors
Chemistry panel
Urinalysis
Haematology panel
ECG
3. Collection of adverse events and review
4. Referring to the test agent Ampligen 'Registered trade mark'.
Timepoint [1] 8631 0
9 weeks

Eligibility
Key inclusion criteria
1. Healthy Normals
2. Age range 60-80 years old
3. Ability to provide written informed consent indicating awareness of the investigational nature of this study
4. Documentation during baseline history, examination and testing that each subject is active and healthy
5. Failure to get the current flu vaccination prior to entry to the study
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Inability to return to scheduled treatment and assessments

2. Chronic or intercurrent acute medical disorder or disease such as:
- unexplained abnormal ESR or C-reactive protein
- rheumatoid arthritis
- lupus
- other autoimmune disease
- obstructive airway diseases whether reversible (asthma) or Chronie Obstructive Pulmonary Disease (COPD)
- diabetes
- allergies to eggs, antibiotics, mercury containing products or vaccines history of anaphylaxis

3. Therapy with:
- immunomodulatory drugs (including gamma globulin, systemic steriods, interferons)
- antivirals (including acyclovir, AZT and/or antiviral nucleoside analogues)
- investigational drugs within the past 6 weeks

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4218 0
Commercial sector/Industry
Name [1] 4218 0
Hemispherx Biopharama Inc.
Country [1] 4218 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Hemispherx Biopharama Inc
Address
One Penn Center, Suite 660,
1617 JFK Blvd
Philadelphia, PA 19103
Country
United States of America
Secondary sponsor category [1] 3792 0
Commercial sector/Industry
Name [1] 3792 0
CNS Pty Ltd
Address [1] 3792 0
Level 3, 88 Jephson Street
Toowong, Brisbane, QLD 4066
Country [1] 3792 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29174 0
Address 29174 0
Country 29174 0
Phone 29174 0
Fax 29174 0
Email 29174 0
Contact person for public queries
Name 12331 0
CNS Project Manager
Address 12331 0
Level 4, 88 Jephson Street Toowong, Brisbane, QLD 4066
Country 12331 0
Australia
Phone 12331 0
+61 7 3331 3933
Fax 12331 0
+61 7 3870 0520
Email 12331 0
cns@clinical.net.au
Contact person for scientific queries
Name 3259 0
CNS Project Manager
Address 3259 0
Level 4, 88 Jephson Street Toowong, Brisbane, QLD 4066
Country 3259 0
Australia
Phone 3259 0
+61 7 3331 3933
Fax 3259 0
+61 7 3870 0520
Email 3259 0
cns@clinical.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.